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LEONIDAS: Quality of Life Study in Chronic Myeloid Leukemia Patients (QoL-CML0713)

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ClinicalTrials.gov Identifier: NCT02164903
Recruitment Status : Unknown
Verified August 2018 by Gruppo Italiano Malattie EMatologiche dell'Adulto.
Recruitment status was:  Active, not recruiting
First Posted : June 17, 2014
Last Update Posted : August 6, 2018
Sponsor:
Collaborators:
European Leukemia Net
CML Advocates Network
Information provided by (Responsible Party):
Gruppo Italiano Malattie EMatologiche dell'Adulto

Brief Summary:
The broad goal of this study is to investigate if differences exist (and in which areas and of what magnitude) in QoL and symptoms of patients with CML being treated with first line therapy with dasatinib versus those receiving first line therapy with imatinib. Also, an additional objective is to characterize medication-taking behavior associated with imatinib or dasatinib.

Condition or disease Intervention/treatment
Chronic Myeloid Leukemia Other: QoL Survey Booklet

Detailed Description:

The development of molecular targeted therapies (i.e., oral tyrosine kinase inhibitors [TKIs]) to treat chronic myeloid leukemia (CML) is one of the great triumphs of modern oncology and one of the spearheads of personalized medicine. Since their introduction in 2001, the number of people living with CML has doubled, a trend that is expected to continue.

This study (i.e., LEONIDAS) is set up to generate evidence-based data and produce information that will advance scientific knowledge, clinical practice and health services management to facilitate clinical decision-making in CML.

In an effort to further promote patient-centered care for CML a patient advocacy organization, that is the: CML Advocates Network, is involved in this project with key representatives who will be in the advisory board team. The CML Advocates Network, hosted by the patient-run, non-profit Leukemia Patient Advocates Foundation is a worldwide network of 82 non-profit organizations from 63 countries supporting patients with CML and their relatives.

Rationale and Significance Some ten years ago, the treatment of CML was relatively straightforward as all patients received imatinib as first-line treatment and for those who failed imatinib, the only available proven alternative was allogeneic stem cell transplantation. Nowadays, with three effective drugs (i.e., imatinib, nilotinib and dasatinib), that can be used frontline in newly diagnosed chronic phase (CP) CML patients, treatment decision-making for individual patients in daily clinical practice has thus rapidly grown in complexity. Moreover, a new tyrosine kinase inhibitors (TKI), bosutinib, has been recently approved for as second-line treatment and undergoing clinical trials are assessing its efficacy as frontline strategy in CML.

To further complicate the scenario, is the fact that despite nilotinib and dasatinib have been shown to have higher rates of cytogenetic and molecular responses (compared to imatinib), none of these three drugs is dramatically better than the others. To illustrate, only slightly differences exist in terms of progression-free survival for nilotinib and no differences for overall survival at 24 and/or 36 months amongst imatinib, dasatinib and nilotinib.

Nevertheless, physician-reported toxicity data suggests these drugs have different toxicity profiles, with imatinib inducing a higher proportion of low-grade side effects than second generation tyrosine kinase inhibitors (TKI) (i.e. nilotinib and dasatinib).

While a wealth of biomedical and laboratory data exists on clinical efficacy of these three drugs, the impact of these from the patients' perspective, in terms of Quality of Life (QoL) and symptom burden, has been poorly investigated. No data exists on QoL of patients treated with nilotinib or dasatinib and it is not known if these drugs provide better QoL outcomes over imatinib when used as first line therapy. Such information would be critical in the current CML arena to make more informed treatment decisions. This is a significant gap in our knowledge with respect to the modern management of CML, also because, as long-term continuous exposure to the tyrosine kinase inhibitors (TKI) is necessary, even low grade side effects can heavily impact on patients' QoL.

Thus, the objective of this study is to investigate if differences exist (and in which areas and of what magnitude) in QoL and symptoms of patients with CML being treated with first line therapy with dasatinib versus those receiving first line therapy with imatinib, as well as characterizing medication-taking behavior associated with imatinib or dasatinib.

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Study Type : Observational
Actual Enrollment : 323 participants
Observational Model: Case-Control
Time Perspective: Cross-Sectional
Official Title: Mid to Long-term Quality of Life Effects Of imatiNIb Versus DASatinib in Chronic Myeloid Leukemia Patients (LEONIDAS)
Actual Study Start Date : September 11, 2014
Actual Primary Completion Date : January 25, 2017
Estimated Study Completion Date : October 2018


Group/Cohort Intervention/treatment
Imatinib
Patients in first line treatment with imatinib for no more than 3 years.
Other: QoL Survey Booklet
Dasatinib
Patients in first line treatment with dasatinib for no more than 3 years.
Other: QoL Survey Booklet



Primary Outcome Measures :
  1. Severity of the impact of therapy on daily life in patients with CP-CML being treated with first line therapy with dasatinib and those receiving first line therapy with imatinib. [ Time Frame: 24 months. ]
    (outcome measure: European Organization for Research and EORTC QLQ-CML24 "Impact on daily life" scale)


Secondary Outcome Measures :
  1. Differences in Patient-reported outcomes between imatinib- and dasatinib- treated CP- CML patients in the following QoL domains: Fatigue, Physical, Social and Role Functioning and Impact on worry and mood and Symptom burden. [ Time Frame: 24 months. ]
    (outcome measure: EORTC QLQ-C30 and EORTC QLQ-CML24)

  2. Proportion of patients considered as low, medium and high adheres by type of therapy. [ Time Frame: 24 months. ]
    (outcome measure: Morisky-Medication Adherence Scale-MMAS)

  3. Relationship between patient's perception of disease-/treatment-related information received , QoL profile and adherence to therapy. [ Time Frame: 24 months. ]
    (defined according to the EORTC-QLQ-INFO25)

  4. Degree of agreement in the assessment of symptom severity, for a set of core CML treatment related symptoms , between patients and their treating physicians. [ Time Frame: 24 months. ]
    (according to the EORTC-QLQ-CML24)



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Adult chronic myeloid leukemia patients in first line treatment with either dasatinib or imatinib for no more than 3 years.
Criteria

Inclusion Criteria:

  • 18 years or older at the time of study entry;
  • Diagnosis of Philadelphia chromosome positive and/or BCR-ABL positive CML confirmed by cytogenetic and/or molecular analysis;
  • At least in CCyR (as documented by chromosome banding analysis of marrow cell metaphases) or in MMR (≤0.1% BCR-ABL IS)
  • CP-CML Patients in first line treatment with either dasatinib or imatinib for no more than 3 years;
  • Written informed consent.

Exclusion Criteria:

  • Major cognitive deficits or psychiatric problems hampering a self-reported evaluation.
  • Not speaking and reading the language of the participating country.
  • Having received any CML treatment prior to therapy with imatinib or dasatinib for more than three months.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02164903


Locations
Show Show 49 study locations
Sponsors and Collaborators
Gruppo Italiano Malattie EMatologiche dell'Adulto
European Leukemia Net
CML Advocates Network
Investigators
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Study Chair: Fabio Efficace, PhD Gruppo Italiano Malattie EMatologiche dell'Adulto
Study Director: Gianantonio Rosti, Dr. University of Bologna
Additional Information:
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Responsible Party: Gruppo Italiano Malattie EMatologiche dell'Adulto
ClinicalTrials.gov Identifier: NCT02164903    
Other Study ID Numbers: QoL-CML0713
First Posted: June 17, 2014    Key Record Dates
Last Update Posted: August 6, 2018
Last Verified: August 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Gruppo Italiano Malattie EMatologiche dell'Adulto:
Quality of Life
Chronic Myeloid Leukemia
Imatinib
Dasatinib
Additional relevant MeSH terms:
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Leukemia
Leukemia, Myeloid
Leukemia, Myelogenous, Chronic, BCR-ABL Positive
Neoplasms by Histologic Type
Neoplasms
Myeloproliferative Disorders
Bone Marrow Diseases
Hematologic Diseases